論文

国際誌
2022年11月12日

Surrogacy analysis of intermediate end-points for overall survival in randomized controlled trials of rhabdomyosarcoma.

Scientific reports
  • Yuta Kubota
  • ,
  • Kazuhiro Tanaka
  • ,
  • Masanori Kawano
  • ,
  • Tatsuya Iwasaki
  • ,
  • Ichiro Itonaga
  • ,
  • Hiroshi Tsumura

12
1
開始ページ
19381
終了ページ
19381
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1038/s41598-022-23944-w

Treatment of malignant tumors, such as rhabdomyosarcoma (RMS), can improve overall survival (OS). It is time-consuming and expensive for patients to obtain benefits from randomized controlled trials (RCTs) with OS as the primary end-point. Therefore, another surrogate end-point is necessary; however, there is no report on the surrogacy analysis of RMS. In this study, we performed a systematic review of RCTs, involving patients with newly diagnosed RMS, and 11 RCTs were identified. We performed a meta-analysis to assess the surrogacy of intermediate end-points for OS. The correlations between surrogate end-points and OS were investigated using Spearman's rank correlation coefficient (ρ). The coefficient of determination (R2) was employed to measure the strength of the association. A total of 5183 patients were randomly allocated to 34 treatment groups. A marginal correlation (R2 = 0.281, ρ = 0.445) between the hazard ratios (HRs) for event-free survival (EFS) and OS was observed. In patients with localized RMS, the EFS HR had a weaker correlation with OS HR in the sensitivity analysis than that in the primary analysis. Overall, the surrogacy of EFS for OS cannot be confirmed.

リンク情報
DOI
https://doi.org/10.1038/s41598-022-23944-w
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/36371419
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9653385
ID情報
  • DOI : 10.1038/s41598-022-23944-w
  • PubMed ID : 36371419
  • PubMed Central 記事ID : PMC9653385

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